An Overview Of The ICH-Q3D Heavy Metal Regulations

whitePaper | April 22, 2022

Members of the Health-ISAC community have produced a security framework for the pharmaceutical supply chain comprising this CISO guide.

whitePaper | November 1, 2022

Equipment cleaning in manufacturing companies is often not given the same emphasis as other processes. It can be viewed as a task.

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

whitePaper | November 11, 2022

Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening (HTS) for drug discovery since the early 1990s.

whitePaper | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

whitePaper | November 24, 2022

The pharmaceutical industry will face many challenges over the next decade, from industry-wide trends to new operational pressures. The key to meeting these challenges is adopting an agile, scalable and efficient approach to drug discovery and manufacturing.